Fixation Devices for Anterior Lumbar or Cervical Interbody Fusion

ABSTRACT

Fixation systems, kits and methods for vertebral interbody fusions are provided. The fixation systems fix an intervertebral cage in the spine to resist left to right rotation, flexion and/or extension. In one embodiment, the fixation system contains two keels that are insertable into an attachment portion or an anterior wall of an intervertebral cage. Each keel contains a blade with two flanges, in the shape of half of an I-beam. The attachment portion may be one or more pieces that mate to form the attachment portion, such as an I-beam attachment portion. The blades can be straight or curved. Preferably the fixation systems are modular, allowing for parts to be interchanged to suit the patient&#39;s needs. The fixation systems may be provided in a kit, preferably with more than two keels having different sizes and/or shapes, more than one cage, and/or more than one attachment portion.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional application Ser. No. 61/695,789, filed Aug. 31, 2012. The disclosure of U.S. Ser. No. 61/695,789 is herein incorporated by reference.

FIELD OF THE INVENTION

This invention relates to devices and methods used in spine surgery, particularly devices and methods used to stabilize cages used in interbody fusions, such as anterior lumbar interbody fusions (ALIF) and lateral interbody fusions (LIF).

BACKGROUND OF THE INVENTION

Anterior lumbar interbody fusion (ALIF) is a type of spinal fusion that utilizes an anterior (front—through the abdominal region) approach to fuse the lumbar spine bones together. The intervertebral disc is removed and replaced with a bone (or metal) spacer, in this case using an anterior approach. The anterior technique is often favored when multiple spinal levels are being fused and multiple discs need to be removed. ALIF may be performed in conjunction with or without a posterior decompression (laminectomy) and/or instrumentation (use of metal screws/rods). The anterior approach is also ideal when only one spinal level is fused and a posterior decompression and/or instrumentation are not required. Although the anterior lumbar approach involves retracting (moving out of the way, temporarily) large blood vessels (aorta, vena cava) and the intestines, there is a wide exposure of the intervertebral disc without refraction of the spinal nerves and neurologic structures (and therefore, a decreased risk of neurologic injury).

ALIF is commonly performed for a variety of painful spinal conditions, such as spondylolisthesis and degenerative disc disease, among others.

The ALIF approach is advantageous in that, unlike the PLIF and posterolateral gutter approaches, both the back muscles and nerves remain undisturbed.

Another advantage is that placing the bone graft in the front of the spine places it in compression, and bone in compression tends to fuse better.

Lastly, a much larger implant can be inserted through an anterior approach, and this provides for better initial stability of the fusion construct.

However, the ALIF procedure also involves resection of the anterior longitudinal ligament, which can destabilize the implanted cage.

Therefore, surgeons often combine ALIF with a posterior approach (anterior/posterior fusions) because of the need to provide more rigid fixation than an anterior approach alone currently provides. Additionally, stabilization and fixation devices have been added to a standard interbody fusion spacer to stabilize and fix the spacer in place.

The lateral approach (LIF) provides an alternate route to the spine that disturbs fewer structures and tissues. This, in combination with small incisions, means much less discomfort for the patient and fewer risks of complications. With a lateral interbody fusion, the surgeon approaches the back through a small incision in the side of the body, using special tools and techniques. There are a number of other names for the same technique, including DLIF® (Direct Lateral Interbody Fusion), XLIF® (eXtreme Lateral Interbody Fusion), and transpsoas interbody fusion.

In most cases, patients who are candidates for this surgery are those who would have needed an incision in the abdomen in order for the surgeon to reach the area of concern. Approaching the spine through the abdomen means the surgeon must get around large blood vessels, nerves, muscles, and organs that are in the way. This can prolong recovery following surgery and, in rare cases, can cause complications such as nerve or blood vessel damage.

Many existing interbody fusion spacer systems require multiple actions on the part of the surgeon with respect to cage insertion, and fixation of the cage to the vertebral bodies.

For example, the INDEPENDENCE® Spacer System (Globus Medical, Inc.) integrates a stabilization plate and a PEEK interbody spacer into a preassembled system. INDEPENDENCE® also incorporates a smooth screw blocking mechanism, minimizing disruption to the anatomy surrounding the surgical site and may lessen the long term impact from surgery. However, this system requires multiple actions by a surgeon to insert and fix it in place.

Additionally the use of a screw fixation system has a number of disadvantages. Screw fixation systems can require the use of a drill or an awl to prepare a hole in the vertebrae. Some screw systems require two different length screwdrivers to insert the screw or an initial driver to insert the screw most of the way into the vertebrae and then a torque driver to do the final tightening.

Screw fixation devices require a specific angle of insertion that requires a larger soft tissue exposure/corridor than necessary to insert the cage itself. Sometimes these angles require undue pressure on the surrounding soft tissues which could place abdominal viscera and blood vessels at risk. These fixed angles required to insert the screws can limit the ability to insert the fixation devices at the L5-S1 disc where the symphysis pubis may inhibit access.

Additionally, the fixed angles for screw insertion and limited soft tissue exposure can place excess pressure on the insertion tool and cause the screw to be inserted inappropriately and possibly strip the screw at the bone-screw interface or the screw-anterior plate interface. This may occur if the device screw uses a separate machine thread to lock the screw to the cage.

While overcoming some of the limitations associated with fixed-angle screw insertion some vertebral fixation systems utilize variable angle screw insertion, however these systems may not provide rigid fixation to the plate/cage and vertebrae. This may allow micro motion and increase the risk of failed fusion.

Screw systems, fixed or variable angle, provide little surface area contact within the vertebra to adequately resist the forces of flexion, extension, rotation, and translation/shear. A fixation system that effectively neutralizes these forces is necessary for rigid fixation. Rigid fixation eliminates the need for supplemental external immobilization devices (braces) and allows early patient mobilization and return to more normal activity.

Instrumentation and specialized tools for insertion of an intervertebral implant is yet another design parameter to consider when designing a spacer. Spinal fusion procedures can present several challenges because of the small clearances around the spacer when it is being inserted into position. For instance, the instrumentation used may securely grip the implant on opposing sides or surfaces. In U.S. Pat. No. 6,520,993 to James, et al., for example, the superior and inferior surfaces have one or more regions in which no gripping teeth are present. These protrusion-free zones enable the implant to be grasped and manipulated by elongate rectangular blades. However, the clearance required to insert the spacer must be higher than the spacer itself to accommodate the required instrumentation. For this reason, distraction of the treated area typically is greater than the implant itself.

Similarly, when the gripping tools used to manipulate and insert the implant on the sides of the spacer, additional clearance typically is needed to accommodate the added width of the insertion tool blades. Such increases in height or width of the profile of the spacer, when in communication with instrumentation, means that additional space is needed in order to insert the spacer. In some circumstances, providing for this additional clearance space can be difficult to achieve.

Thus, despite known devices that promote fusion of a treated area of the spine, there remains a need for improved fixation devices for use in interbody fusions, such as ALIF and anterior cervical discectomy and fusion.

Therefore it is an object of the invention to provide improved fixation devices and kits for interbody cages.

It is a further object of the invention to provide improved methods for achieving vertebral interbody fusions, in the lumbar or cervical spine.

SUMMARY OF THE INVENTION

Fixation systems, kits and methods for vertebral interbody fusions are provided herein. The fixation systems fix an intervertebral cage in its desired location, typically in the lumbar or cervical spine, such that the cage resists left to right rotation and resists flexion and/or extension. Additionally, the fixation elements are locked in place to prevent accidental removal from the cage. In one embodiment, the fixation system contains two deployable blades (also referred to herein as keels) that are insertable into an attachment portion or an anterior wall of an intervertebral cage. Each keel contains a blade with two flanges, wherein the cross-section of the keels is in the shape of half of an I-beam. In some embodiments the anterior wall is permanently attached to the cage. In others it is an attachment portion that is configured to be received by and attached to an intervertebral cage. The attachment portion may be one piece or two or more pieces that mate to form the attachment portion. In one embodiment, the attachment portion is formed from two pieces that form an I-beam with a central opening, where the central opening is configured to receive both of the blades.

The blades can straight or curved. Following insertion into the cage, the blades insert into the superior and inferior vertebral bodies.

In a second embodiment, two blades are insertable into the superior and inferior sides of a cage, such as by sliding the blades in a channel that mates with the bottom, attachment portion on the blades. The blades can be integral or separate from a front plate, which locks onto the anterior portion of the cage. In a preferred embodiment, the blades are integral with the front plate and the system contains an inner plate with one or more holes for additional fixation elements, such as screws of fluted nails. Any of the systems may be modified to include further fixation elements, such as fluted nails, and/or additional locking elements.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate an exemplary fluted nail. FIG. 1C illustrates a portion of a front plate with holes that mate and guide the fluted nails.

FIGS. 2A-D are different views of an ALIF cage with a front (outer) plate containing two blades (also referred to as keels). FIG. 2A is an anterior perspective view of the ALIF cage with an inner plate attached to the anterior portion of the cage. FIG. 2B is the same perspective view as shown in FIG. 2A, with two fixation elements, such as a superior and an inferior fluted nail, inserted therein. FIG. 2C is a perspective view of the fixation device, including the two fixation elements, also showing the insertion of the outer plate with two keels into the cage. FIG. 2D is a perspective view of the fully assembled fixation device.

FIGS. 3A-F are different views of an ALIF cage with I-beam fixation and two keels. FIG. 3A is an exploded view of the I-beam attachment portion and the ALIF cage. FIG. 3B is a perspective view of the I-beam attachment portion with the keels attached, where the blade of the keels is curved. FIG. 3C is a perspective view of the I-beam attachment portion with the keels attached, where the blade of the keels is straight. FIG. 3D is an anterior perspective view of the fixation device. FIG. 3E is a front plan view of the I-beam attachment portion. FIG. 3F is a side view of the I-beam attachment portion showing the grooves.

FIGS. 4A-D are different views of the ALIF cage with locking element for two screws or fluted nails. FIG. 4A is a posterior view of the locking element. FIG. 4B is a posterior perspective view of the ALIF cage containing a front plate inserted therein. FIG. 4C is an anterior exploded view of the ALIF cage with two fixation elements and the locking element. FIG. 4D is a perspective view of the fully assembled fixation device.

FIGS. 5A-C are illustrations of different locking elements. FIG. 5A is an illustration of a locking element for three fixation elements, such as screws or fluted nails, in a cage. FIG. 5B is an illustration of a locking element for two fixation elements in a cage. FIG. 5C is an illustration of a further embodiment for a locking element for two fixation elements in a cage.

FIGS. 6A-H are illustrations of an embodiment for locking a keel in a desired position within a cage using a locking tab. FIG. 6A is an illustration of a keel containing a locking tab. FIGS. 6B-I are different views illustrating a keel locked inside a cavity of half of an I-beam attachment portion. FIG. 6B is a perspective view, FIG. 6C is a top view, FIG. 6D is a side view, and FIG. 6E is the opposite side view. FIG. 6F is a side view of the keel in a locked position in the half I-beam portion. FIG. 6G is the cross-sectional view A-A of FIG. 6F. FIG. 6H is a side view of the keel in an unlocked position in the half I-beam portion. FIG. 6I is the cross-sectional view A-A of FIG. 6H.

FIGS. 7A-D are different views of an ALIF cage with deployable blades (also referred to as keels). FIGS. 7A and 7B illustrate the ALIF cage with the blades protruding out the anterior wall. FIGS. 7C and 7D illustrate the ALIF cage with the blades deployed so that they would be inserted into the superior vertebral body and the inferior vertebral body. FIG. 7A shows the lateral wall with the posterior side of the device at the top and the anterior side of the device at the bottom. FIG. 7B is a top view illustrating the deployable keels protruding from the anterior wall. FIG. 7C is a perspective view; FIG. 7D is a front view of the cage with the blades in a deployed position.

DETAILED DESCRIPTION OF THE INVENTION I. Fixation Systems

The fixation systems described herein fix an intervertebral cage in its desired location, to resist left to right rotation and to resist flexion and/or extension of the cage. Additionally, the fixation elements are locked in place to prevent accidental removal from the cage. When assembled, the implant is contained within the excised disc space and does not protrude past the anterior wall of the vertebral body. Thus the system has a zero anterior profile. Additionally, preparations of anterior surface of the vertebral body are minimized because the implant does not lie against this surface.

In some embodiments, the fixation system is preassembled. When the front plate and cage are preassembled, the plate is automatically aligned upon implant insertion. This simplifies the insertion process, preventing the need to align and realign the front plate.

The systems can be used for anterior, posterior or lateral approaches. The devices can be single-use or re-usable. In one embodiment only the keels are re-usable. In another embodiment, only the cage is reusable. The device may be removed from the patient, the keels discarded, and a new set of keels inserted into the device before the device is then re-inserted into the patient. In other instances, the entire device can be removed from the patient and then later re-inserted.

A. Cage

An intervertebral cage, having a three dimensional body suitable for insertion between vertebrae is provided. The cage serves as a spacer, to ensure that the desired distance between the vertebrae is maintained. The cage contains one or more openings, typically two openings for the insertion of bone graft material. The cages allow the bone graft to grow from the vertebral body through the cage and into the next vertebral body.

In addition to the features shown in the Figures, the cages and fixation systems may contain one or more threaded holes, slots or channels to mate with instruments to facilitate holding and inserting the implants.

The cage contains one or more areas for attaching or inserting one or more fixation elements to resist left to right rotation and to resist flexion and/or extension of the cage. Following insertion of the one or more fixation elements, the fixation elements remain in the resulting system, i.e. pull out and/or translation of the fixation elements is prevented.

The cage can be formed from any suitable biocompatible, non-degradable material with sufficient strength. Typical materials include titanium and inert, biocompatible polymers, such as polyether ether ketone (PEEK) (e.g. PEEK-OPTIMA®, Invibio Inc). Optionally, the cage contains a radiopaque marker to facilitate visualization during imaging.

In some embodiments, the wall or a portion thereof, through which the fixation elements are inserted or attached, is formed from a different material than the rest of the cage. For example, most of the cage depicted in FIGS. 7A-7C is generally formed from a first material, such as PEEK, while the anterior wall (912) of the cage is formed from a second, different material, such as titanium or another biocompatible material with a similar strength. Preferably, the anterior wall is affixed to the rest of the cage in a permanent manner.

Generally, the cage is adapted for insertion within an intervertebral space between a superior vertebral body and an inferior vertebral body and includes a first insertion end portion, a second end portion opposite the first end portion, a first lateral side portion, a second lateral side portion, an upper surface and a lower surface.

The upper and lower surfaces of the cage, which contact the superior vertebral body and the inferior vertebral body, typically contain teeth, knurling, ridges or similar projections, to aid in securing the implant to the vertebral endplate and preventing or reducing any shifting of the implant. This also provides initial stability following implantation.

The particular surface shape and curvature, or taper in the anterior-posterior direction as well as between the lateral side surfaces depends upon the location at which the cage is intended to be inserted. For example, the anterior:posterior dimension of the LIF cage is less than the anterior:posterior dimension of the ALIF cage to allow insertion from a lateral approach. Typical anterior:posterior dimensions for LIF cage range from about 18 to 24 mm, while for the ALIF, typical anterior:posterior dimensions range from about 26 to 31 mm. The left to right dimension of the LIF cage is typically longer than the left to right dimension in an ALIF cage so that it can span the entire width of the vertebral body. The shape of the perimeter of the cage can be modified for lumbar applications, or for other areas such as in the cervical area of the spine.

The cage and its fixation elements can be implanted in the desired location in a patient using known surgical instruments. The number and position of access through-holes, e.g. two, three, four or the like, is dictated by the particular patient's anatomy or other surgical considerations, and is also not intended to be limited by the type of attachment mechanism between the implant and instrumentation.

The implants described herein may be sized and configured for anterior, posterior or lateral approaches and insertion.

B. Fixation Elements

One or more fixation elements are provided for insertion into and/or attachment to the intervertebral cage. The fixation elements provide stabilization in flexion and lateral bending, and also in extension and rotation. The fixation elements are attached to the intervertebral cage to prevent them from slipping out or being pulled out of place, absent surgery or another method of intentional removal of the fixation elements.

Following insertion into a patient, and optionally deployment, the fixation elements anchor the cage into cancellous bone of at least one vertebral body.

1. Fluted Nail

In one embodiment, the one or more fixation elements include one or more fluted nails, preferably at least two fluted nails. An exemplary fluted nail is illustrated in FIGS. 1A and 1B. As shown in FIGS. 1A and 1B, the fluted nail (100) contains one or more grooves (112 a, b, c) that run along the length of the body of the nail in a helical pattern. As shown in FIG. 1B, the nail may contain three grooves. Typically the fluted nail contains at least two helical grooves, preferably the nail contains three helical grooves, optionally the nail contains more than three helical grooves. The fluted nail has longer pitch than standard threads on screws. Suitable pitches include 5-10 mm.

Fluted nails with suitable dimensions for placement in the cages and insertion into the proximal vertebra of the spine may be used. For example, the nail shank may range from about 4.5-6 mm in diameter and from about 20-40 mm in length. The head of the nail may range from about 5.5-7 mm in diameter, depending on the nail shank diameter. The depths from the grooves may range from about 1-1.5 mm.

In one embodiment the fixation elements include two fluted nails. In an alternative embodiment, the fixation elements include three fluted nails. In yet further alternative embodiments the fixation elements include at least one fluted nail, optionally two or more fluted nails, optionally three or more fluted nails, or optionally four or more fluted nails.

In some embodiments, the fixation system also includes a front plate (114) which affixes to the anterior side of the intervertebral cage (see FIG. 1C). In this embodiment, the front plate contains one or more, preferably two, openings (116 a, b, c) with a shape that matches the cross-section of the body of the fluted nail (see, e.g. FIGS. 1B and 1C). The front plate can serve as a locking mechanism for the fluted nails by preventing the nails from unscrewing or sliding out of the hole into which it is inserted.

a. Insertion and Implantation

The fluted nail can be forced into place, such as using a hammer. As it is hammered in place, the fluted nail rotates along the path of grooves, as guided by the openings in the front plate, until the head of the nail is essentially flush with the outer surface of the front plate 114. This prevents the nail from backing out after it is inserted into the desired location. Additionally, the rotation of the nail during its placement compresses the surrounding bone, further restricting movement of the nail following placement.

2. Keel

In some embodiments, the one or more fixation elements include one or more bone engaging projections. Suitable bone engaging projections include but are not limited to blades, fins, spikes, keels, ridges, knurlings, or a combination thereof. Preferably the bone engaging projections are one or more keels, more preferably two keels. Following insertion, and, if necessary deployment, the distal tip of each keel extends above or below the cage and is inserted into the superior vertebral body or the inferior vertebral body to increase the stability of the cage. The keels can extend in a substantially perpendicular (220) direction relative to the cage (i.e. approximately 90° relative to the upper and lower surfaces of the cage) or at a different angle relative to the upper and lower surfaces of the cage. The keels that are deployed at an angle other than 90° can be longer than the keels that extend in a direction that is generally perpendicular to the upper and lower surfaces of the cage. The longer keels increase the stability of the cage relative to the same cage with keels deployed at a substantially 90° angle.

Typically when deployed, each keel protrudes about 3 to 6 mm past the superior and inferior surfaces of the cage.

The keels can have any suitable geometry that allows them to insert into the proximal vertebral body and remain in place. In one embodiment the keels are substantially straight (460); in another embodiment the keels are curved (420). In one embodiment, keels with different geometries are provided in a kit. This allows a user to select the appropriate keel for the patient. For example, a surgeon may select to use one curved keel and one straight keel, or two curved keels or two straight keels. The radius of curvature can vary. The radius of curvature is preferably selected to provide a sufficient length of keel that penetrates the bone, while also maintaining the blade within confines of the cage.

Preferably each keel contains a blade with two flanges, wherein the cross-section of the keels is in the shape of half of an I-beam.

a. Deployable Keel(s)

i. Deployed by Pushing

In one embodiment, the keels are inserted into the cage in slidable relation to the cage, such that in the initial position, the keels protrude out of the anterior wall. When the keels are deployed, they are pushed through the anterior wall, such that the tips of the keels pass through the inside of the cage, exit the cage, and extend into the proximal superior or inferior vertebral body. The height and shape of the cage and keels is selected such that following implantation and deployment of the keels, the cage and the keels do not add to the anterior profile of the vertebral column.

1. Keels

As shown in FIGS. 7A and 7B, relatively long keels, such as keels ranging in length from about 5 mm to about 10 mm, can be used in devices into which the keels are insertable into and through the anterior wall (912). In this embodiment, when initially inserted, the keels (920 a and 920 b) protrude out the anterior wall (912). See, e.g., FIGS. 7A and 7B.

Preferably each keel contains a flange (926 a and 926 b) on each side of the blade (924) to prevent the keel (920) from sliding out of place after it is deployed in the patient. Each flange is generally perpendicular to the blade. Preferably the cross-section of the keel (i.e. blade and flanges) is in the shape of half of an I-beam, where an I-beam is split in half along a central longitudinal line (running along the length of the blade portion).

The keels have suitable dimensions to fit inside the cage and slide through the slots or cavities at an angle less than 90° relative to the superior or inferior surfaces of the cage. Suitable keels typically have widths ranging from about 1.5 to 3 mm and thicknesses ranging from about to 8 mm. The keels can be curved or straight.

2. Cage

The cage (10) contains an anterior wall (912). See, e.g., FIGS. 7A and 7B. In some embodiments the anterior wall is permanently affixed to the rest of the cage. In other embodiments the anterior wall is insertable into the cage. In either embodiment, the anterior wall is inserted into and attached to the cage prior to implantation in a patient.

The anterior wall (912) of the cage includes one or more slots (also referred to herein as cavities) (913), typically two cavities (such as illustrated in FIGS. 7A-7D) into which a keel is inserted and through which the keel slides to reach its deployed position.

Each cavity contains two grooves (914 a and 914 b) that direct the keel in a downward or upward direction relative to the horizontal plane through the center of the cage at an angle suitable to allow the keel to exit the cage and extend into the proximal vertebral body. See, e.g. FIG. 7D. For straight keels, the angle of each keel (and the groove that directs the keel) relative to the horizontal plane in the center of the cage is generally less than 90°. The shape of each cavity corresponds with the cross-section of the keel that is inserted therein. For example, as shown in FIG. 7D, the cavity may have the shape of a half of an I-beam, with a long portion that corresponds with the length of the blade of the keel and two short portions at the top and bottom of the cavity, that correspond with the length of each of the flanges.

Optionally, the keels can be locked in place when in the deployed position. For example, the anterior wall (or front plate) could include a locking mechanism, such as illustrated in FIGS. 6A-6H.

3. Assembly and Implantation

After an anterior incision is made and the discectomy is completed, the cage is implanted into the disc space. Following implantation of the cage, the keels are inserted into each of the cavities, such that initially, each keel protrudes out the anterior wall of the cage, such as illustrated in FIGS. 7A and 7B. The keels are pushed through the anterior wall such that the tips of the keels pass through the inside of the cage, exit the cage and extend into the proximal superior and inferior vertebral bodies, respectively. FIGS. 7C and 7D show the location of the keels relative to the cage in the deployed position. When deployed, the keels extend into the proximal superior and inferior vertebral bodies for a sufficient distance to retain the cage in the disc space. Following implantation of the cage and the keels, the cage and the keels do not add to the anterior profile of the vertebral column.

3. Outer Plate with Keel(s)

In one embodiment, such as illustrated in FIGS. 2A-2D, the fixation system (300) contains an intervertebral cage (10), an inner plate (310), and an outer plate, also referred to as a front plate (340). Optionally, the system includes additional fixation elements, such as one or more screws or fluted nails (100 a and 100 b).

a. Inner Plate

The inner plate affixes directly to the anterior side of the intervertebral cage. The inner plate also typically contains one or more, preferably two, holes (314 a and 314 b) for receiving a fixation element, such as a screw or a fluted nail. Preferably the cross-section of the hole mates with the cross-section of the screw or nail.

Any suitable means for affixing the inner plate to the intervertebral cage can be used. As illustrated in FIG. 2A, the inner plate may contain an extension portion (316 a and 316 b) on each side (317 a and 317 b) of the plate. The extension portion extends beyond the outer face of the side of the plate and has a suitable size to fit in slidable relation to a slot (352) in the cage (10).

The inner plate also contains a first slot (312 a) on the superior side of the plate and a second slot (312 b) on the inferior side of the plate. These slots have a size and shape suitable for receiving the bottom portion of a keel. In a preferred embodiment, the slot has a T-shaped cross-section.

Preferably the inner plate contains a central bore (318) having a suitable size and shape for receiving a locking screw.

Any suitably strong, biocompatible and inert material can be used for the inner plate. In a preferred embodiment, the inner plate is formed from titanium.

b. Outer Plate

The outer plate (340) contains a top keel (320 a) and a bottom keel (320 b). The top and bottom keels have a keel attachment portion (324) with a size and shape that is suitable for slidable insertion into a channel (350) in each of the superior (354) and inferior (not shown) outer surfaces of the cage.

The outer plate also contains at least one bore (not shown) having a size and shape suitable for receiving a locking means preferably a screw (330), which can be turned to lock the outer plate in place following insertion into the cage. (see, e.g. FIGS. 2C and 2D). Preferably the bore is threaded to mate with the threads on the locking screw.

The outer plate can also serve as a locking means for the keels by preventing the keels from sliding out of position.

Preferably the outer plate has a suitable size and shape, optionally a rectangular shape as illustrated in FIG. 2C, to cover the inner plate. In this embodiment, the outer plate serves as a front plate, which locks the inner plate in place so that it remains affixed to the anterior side of the intervertebral cage.

c. Cage

The cage (10) contains a first channel (350 a) on the superior side of the cage and a second channel (350 b) on the inferior side of the cage. These channels have a size and shape suitable for receiving the bottom portion of a keel. In a preferred embodiment, the slot has a T-shaped cross-section.

The cage (10) preferably contains a bore having a size and shape suitable for receiving a locking means preferably a screw (330).

d. Assembly and Implantation

Prior to insertion in a patient's body, the inner plate is assembled with the cage, such as by sliding the extension portions (316 a and 316 b) in the slots (352 a and 352 b) to attach the inner plate to the anterior portion of the cage. After the discectomy is completed, the cage is implanted into the disc space between the vertebral bodies in a patient. Preferably following insertion of the cage, the cage is fixed in place using one or more fixation elements, such as by inserting screws or fluted nails into the one or more, preferably two, holes (314 a and 314 b) in the inner plate. Then the keels are attached to the cage by sliding the keel attachment portion in the channel (350) in each of the superior (354) and inferior (not shown) outer surfaces of the cage. Finally the outer plate is locked in place by inserting a locking screw into the bore in the outer plate and rotating the screw until it is flush with the anterior surface (342) of the outer plate.

4. Keels Attachable to the Cage

In one embodiment, the cage contains a first channel, such as a “T” channel, on the anterior surface and a second channel on the inferior surface, such as illustrated in FIG. 2A, as described above. The size and shape of the channels are suitable for insertion of a keel into each of the top and bottom surfaces.

Instead of using keels that are integral with an outer plate, the keels can be separate from the outer plate. Each keel can slide into one of the channels of the cage. Then a front plate, optionally with one or more holes for fixation elements, such as screws or fluted nails can be affixed to the anterior portion of the cage. Further the plate has a suitable size and shape to cover at least the keel attachment portion of each of the keels and thereby lock the keels in place. The front plate locked in place by inserting a locking screw into the bore in the outer plate and rotating the screw until it is flush with the anterior surface (342) of the outer plate.

In alternative embodiments, the keels can be moved into the desired position through slots in the anterior portion of the cage or anterior plate and then deform or bend so that the keels lock in place. An exemplary embodiment of a locking blade and corresponding slots or cavities in the cage is illustrated in FIGS. 6A-I.

3. I-Beam Fixation

In one embodiment the intervertebral cage is stabilized by two keels that cross each other when placed inside the cage and the anterior ends of the keels are able to lock in the desired location, such as by interlocking with each other to form an I-beam, or by other suitable locking means. For example, one end (the proximal end) may be located in or attached to two portions that interlock to form an I-beam attachment portion. Preferably this embodiment does not require a front plate to attach the keels and lock them in place. The flanges in the I-beam attachment portion preferably form a dove tail joint in the cage, preferably in the anterior region of the cage, to prevent its removal (pullout) from the cage.

In one embodiment, the cross section of each keel's blade forms half of an I-beam attachment portion. At least one of the blades contains grooves that allow the second blade to mate with an interlock with the first blade when the blades are placed inside the cage. Once assembled, the interlocked blades resist rotation of the cage and the I-beam formed at the anterior end of the assembly resists flexion/extension and pullout/translation of the cage.

FIGS. 3A-3F illustrate one embodiment of a device that utilizes I-beam fixation. As shown in FIG. 3D, the device contains an intervertebral cage (10) and an I-beam fixation system (400), which preferably contains a first (410 a) and a second (410 b) half I-beam portion, and at least one keel, preferably two keels (420 a and 420 b).

a. Half I-Beam Portions

As shown in FIGS. 3A, E, and F, the first (410 a) and second (410 b) half I-beam portions mate to form an I-beam attachment portion (430) which is insertable in slidable relation to the slots (452 a and 452 b) in the anterior portion (456) of the cage (10).

Each half I-beam portion contains an extension portion (412) on one side (411), where the extension portion has a size and shape suitable for slidably inserting it into the first and second slots (452 a and 452 b) in the cage (10).

As shown in FIG. 3F, each half I-beam portion also contains a cavity (413) for receiving the keel, which optionally contains one or more grooves (414 a and 414 b), typically two grooves on the side of the half I-beam portion that is opposite the extension portion. The cavity has a suitable shape and size to receive one of the keels. Each groove is a depression that has a suitable shape and depth for receiving the flange on the blade of the keel. In a preferred embodiment, in one half I-beam portion, the grooves are angled downward to direct the keels to the inferior vertebral body, while in the other half I-beam portion, the grooves are angled upward to direct the keel to the superior vertebral body.

b. Keels

As shown in FIGS. 3B and C, the keels may have a keel attachment portion (422 a and 422 b) with a size and shape that is suitable for insertion into a depression (350) in the anterior portion of the cage.

The keel also contains a blade portion (424 or 460) having a suitable shape and size. The blade portion is oriented to extend the tip (428) of the blade portion beyond the superior (458) or inferior surface of the cage when the fixation system (400) is assembled, such that the tip of the blade portion enters and extends into the proximal vertebral body. Preferably the blade portion is curved to facilitate placement in the proximal vertebral body (see FIG. 3B). In an alternative embodiment, the blade portion may be straight (see FIG. 3C).

Preferably each keel also contains a flange (426 a, 426 b or 466 a, 466 b) on each side of the blade (424 or 460) to prevent the keel from sliding out of place after it is deployed in the patient. Preferably the cross-section of the keel (i.e. blade with flanges) is in the shape of half of an I-beam.

c. Cage

The cage (10) contains an open region (454) in the center of the anterior portion (456) of the cage. The open region contains a first slot (452 a) and a second slot (452 b) on the right and left sides of the anterior portion of the cage. In one embodiment, the slots have a size and shape suitable for receiving the extension portions (412 a and 412 b) of the I-beam attachment portion (430). In a preferred embodiment, the slot has a T-shaped cross-section.

The cage (10) preferably contains a depressed area (450 a and 450 b) on each side surrounding the opening (454) in the anterior portion of the cage. The depressed area has a size and shape suitable for receiving a locking means, preferably formed by the keel attachment portion in proximal end of the keel.

In an alternative embodiment, the slots contain one or more locking means which are configured to deform the proximal portions of each keel (see FIGS. 6A-E).

d. Assembly and Implantation

Prior to insertion in a patient's body, the I-beam attachment portion (430) is assembled and inserted into the cage, such as by sliding the extension portions (412 a and 412 b) in the slots (452 a and 452 b) to attach the I-beam attachment portion to the anterior portion of the cage. After the discectomy is completed, the cage is implanted into the disc space between the vertebral bodies in a patient. Preferably following insertion of the cage, the cage is fixed in place using one or more fixation elements, such as by inserting one or more, keels into the cage by sliding one keel along the grooves (414 a and 414 b) and through the opening (432) in the I-beam attachment portion and sliding a second keel along the grooves (414 c and 414 d) and through the opening (432) in the I-beam attachment portion until their proximal portions (422 a and 422 b) are adjacent to the depressed portions (450 a and 450 b) of the cage.

In some embodiments, the cage does not contain depressed portions. Optionally, each slot contains one or more locking means configured to deform the proximal portion of each keel so that the keel locks in place.

4. Locking Mechanism

Optionally, two or more additional fixation elements, such as screws, fluted nails or pins can be inserted into the cage to prevent the fixation elements from moving out of their intended location using a suitable locking mechanism (500). The locking mechanism is formed from a biocompatible, non-degradable material, with sufficient strength. Suitable materials include but are not limited to stainless steel and titanium.

The locking mechanism is typically attached to the front plate or the anterior portion of the cage (600) via a connection element. Typically, the front plate contains a hole (610) into which a mating connection element in the locking mechanism fits. The anterior face (502) of the locking mechanism has a suitable size and shape to cover in whole or in part the heads of the two or more fluted nails or other fixation elements. A representative shape is illustrated in FIG. 4C, which contains two horizontal, extension portions (503 a and 503 b) that partially cover two fixation elements. Alternative embodiments and shapes are illustrated in FIGS. 5A-C. In one embodiment, the locking mechanism is in the shape of a figure eight (see FIG. 5B) or a circle if only two fixation elements are covered. In another embodiment for covering three fixation elements, the locking mechanism is in the shape of a circle with a sufficient diameter to cover at least a portion, or all, of the head portion of the fixation elements.

Another representative shape for the locking mechanism is illustrated in FIG. 5A as a circle (702) with open portions (704), typically equally spaced about the circumference of the circle. Preferably the head has three openings. The open portions are of a suitable size to allow a fluted nail, including the head of the nail, to pass through. In the unlocked position, the open portions align with the bores in the front plate. Then the fluted nails or other fixation elements are inserted through each open portion and into the corresponding bore until the head of the nail or other fixation element is substantially flush with the surface of the front plate and is below the head of the locking mechanism. Then the locking mechanism is turned, if necessary using a suitable device, until the head of the locking mechanism covers all or a portion of each of the fixation elements. This position corresponds with the locked position.

Optionally, the locking mechanism contains multiple components. An exemplary embodiment is illustrated in FIGS. 4A-D. In this embodiment, the locking mechanism (500), contains a front locking portion (504), a plate (502) having a suitable size and shape to cover in whole or in part the heads of the two or more fluted nails or other fixation elements, optionally with one or more keels (506 a and 506 b), and a back locking element (508). As shown in FIG. 4C, the front locking portion contains two horizontal, extension portions (504 a and 504 b) that partially cover two fixation elements. The keels (506 a and 506 b) are integral with the front locking portion and extend in a generally perpendicular direction relative to the extension portions, with one keel extending in the superior direction and the second extending in the inferior direction. The front locking portion also contains a central bore (510) having a size and shape suitable for mating with the front and back locking elements. The front locking element has a smaller diameter and fits inside the central bore. The back locking element has a central hole with a diameter that is slightly greater than the diameter of the front locking portion such that the back locking element fits over the posterior portion of the front locking element. The back locking portion also contains two flanges (509 a and 509 b).

Prior to insertion, the ALIF cage and the front plate (620) are assembled. The cage is then inserted between the two vertebrae in need of treatment. Then the fixation elements, such as fluted nails or screws, are inserted through the holes in the front plate until the head of the fixation element is essentially flush with the anterior face of the front plate. The locking mechanism is preassembled and then inserted into a central bore in the front plate. After insertion, the locking mechanism is locked in place by rotating the head of the front locking portion. This rotation also rotates that back locking element such that the flanges extend beyond the diameter of the central bore, preventing accidental pull out from the front plate/cage assembly. When fully assembled, the extension elements on the front locking portion (504) partially or fully cover each head of the fixation elements, thereby preventing their accidental removal, or pull out from the front plate/cage assembly.

In one embodiment, the locking mechanism can be formed when a portion of the keels contacts or passes a region of the cavity or slot in the I-beam housing or cage. Preferably one or more locking elements are located in a cavity in the anterior portion or wall of the device, more preferably in an I-beam attachment portion or in a cavity in the anterior wall (or attachment portion) of the cage.

For example, as illustrated in FIG. 6A, each keel (720) may contain a U-shaped channel (722) at its proximal end (726) which defines a deformable tab (724). The tab in the center of the U-shaped channel is shown in its initial, unlocked position. The tab (724) can be deformed into a locked position, and can later be returned to its initial, unlocked position.

As illustrated in FIGS. 6B-6E, the half I-beam attachment portion (710) contains a cavity (714) configured to receive the keel so that it can slide though the cavity into a deployed position. One side of the cavity contains a protrusion (716) configured to push the tab when the keel slides through the cavity. The opposite side of the cavity contains an opening (718) configured to receive the tab, when it is pushed and deformed by the protrusion.

As the proximal portion (726) of the keel slides through the cavity past the protrusion (716), the protrusion pushes the tab (724) into the opening (718). This locks the keel into the deployed position. FIGS. 6F and 6G illustrate the keel in the locked position within the half I-beam attachment portion (710). Once the keel reaches the deployed position, the locking tab is deformed to the locked position preventing mobility of the keel. This locking mechanism prevents the keel from sliding forward or backward. Optionally, an instrument is inserted in the cavity (labeled “cavity 1” on FIG. 6G) and pushes the tab into a bent or locked position.

FIGS. 6H and 6I illustrate the keel in the unlocked position within the half I-beam attachment portion (710). For example, a suitable tool or instrument can be inserted into the cavity (FIG. 6I) and pushes the tab to bend the tab back to its initial, unbent state (i.e. the unlocked position).

II. Kits Containing the Device

The fixation device may be provided as part of a kit for an ALIF, anterior cervical fusion or lateral interbody fusion (LIF). The kit may contain an intervertebral cage and at least one fixation device. Preferably the kit contains one or more keels, typically it contains at least two keels. Preferably, the kit contains one or more fluted nails, more preferably at least two fluted nails. In some embodiments, the kit contains three fluted nails, optionally more. The kit also contains instructions for care and insertion of the spinal fixation system.

In some instances it may not be clear what size or shape keels are needed until the surgery has begun. Having a kit that provides several options allows for the device to be altered based on unforeseen circumstances or anatomical circumstances. The kit may provide a modular fixation device, with one or more different intervertebral cages, optionally different sized cages, more than one different sized and shaped keels and more than one type of attachment portion. The attachment portions may be an anterior wall configured to attach to the rest of an intervertebral cage, two half I-beam portions configured to attach to an intervertebral cage to complete the anterior portion of the cage, or a front plate, optionally with a back plate. Optionally, multiple anterior walls are provided containing different angles for the two cavities and/or different shaped cavities, where some are configured to receive straight keels and others are configured to receive curved keels.

In another embodiment, optionally the kit contains different half I-beam portions containing different locking means.

The kit can include curved and/or straight keels and/or keels of different sizes. This allows for each device to be assembled as needed on site. The practitioner can select the appropriate keels for the individual patient.

In one embodiment, more than one cage is provided in the kit. A cage specific for angled keels and a cage specific for keels that are perpendicular to the bone can be supplied. In some instances, a cage that allows for the keels to protrude out the anterior wall is also provided. Because different keels can be used for each of the different cages, a variety of keels can also be provided in the kits.

In one embodiment, the kit can contain preassembled cages.

The kit may also include tool(s) for placement of the cage and fixation device. In one embodiment, the kit can include tools and materials for inserting bone graft material. For example, the kit can include a syringe or other apparatus for injecting bone graft material.

Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed invention belongs. Publications cited herein and the materials for which they are cited are specifically incorporated by reference.

Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims. 

I claim:
 1. A fixation system for insertion into an intervertebral cage comprising two keels and an attachment portion, wherein each keel contains a blade and two flanges, wherein the cross-section of the keels is in the shape of half of an I-beam, and wherein the keels are configured to be received by the attachment portion, and wherein the attachment portion is configured to be received by an intervertebral cage.
 2. The fixation system of claim 1, wherein the keels are straight or curved.
 3. The fixation system of claim 1, wherein the proximal end of each keel comprises a deformable tab, preferably surrounded by a U-shaped channel.
 4. The fixation system of claim 1, wherein the attachment portion further comprises a protrusion and an opening, wherein the protrusion is configured to push the deformable tab into the opening.
 5. The fixation system of claim 1, wherein the attachment portion comprises two cavities, wherein each cavity has a suitable shape to receive one keel such that the keel can slide within the cavity.
 6. The intervertebral implant of claim 3, wherein the cavity is configured to guide the keel through the cavity to slide an angle less than 90° relative to a superior or inferior surface of the cage.
 7. The intervertebral implant of claim 1, wherein the attachment portion is formed of one biocompatible material and wherein the cage is formed of a second biocompatible material.
 8. The fixation system of claim 1, wherein the attachment portion is formed from a first and a second half I-beam portion configured to mate to form an I-beam attachment portion, wherein the resulting I-beam attachment portion comprises a central opening.
 9. The fixation system of claim 8, wherein each half I-beam portion further comprises one or more grooves, preferably two grooves on the side opposite the extension portion, wherein the grooves have a suitable shape and size to receive one of the keels.
 10. The fixation system of claim 8, wherein each keel further comprises a keel attachment portion, and wherein the keel attachment portion is configured to be received by an anterior face of the I-beam attachment portion when the fixation device is assembled.
 11. A kit comprising the fixation system of claim 1 and at least one intervertebral cage.
 12. The kit of claim 11, further comprising more than two keels, wherein the keels have different sizes and/or shapes.
 13. The kit of claim 11, wherein the blade of at least one keel is curved and the blade of at least one keel is straight.
 14. The kit of claim 11, further comprising more than one intervertebral cage, wherein each cage has a different size and/or shape.
 15. The kit of claim 11, wherein the intervertebral cage comprises an open region in the center of the anterior portion of the cage, wherein the ends of the open region have a size and shape suitable for receiving the attachment portion.
 16. The kit of claim 11, further comprising more than one attachment portion, wherein each attachment portion is configured to fit within at least one cage.
 17. A method for fixing an intervertebral cage to resist left to right rotation and to resist flexion and/or extension of the cage following implantation in a patient's body comprising: (a) inserting the attachment portion into the cage to form a cage with an anterior wall, (b) implanting the assembled cage within an excised disc space in a patient in need of treatment, and (c) inserting the keels through the attachment portion in the anterior wall such that the blade inserts into cancellous bone of the proximal superior and inferior vertebral bodies.
 18. The method of claim 17, wherein the attachment portion contains two cavities, wherein in step (c) one keel is inserted into each of the cavities.
 19. The method of claim 17, wherein the attachment portion is formed from a first and a second half I-beam portion that mate to form an I-beam attachment portion, wherein the resulting I-beam attachment portion comprises a central opening, wherein in step (c) the keels are inserted through the central opening.
 20. A method for fixing an intervertebral cage to resist left to right rotation and to resist flexion and/or extension of the cage following implantation in a patient's body comprising: (a) implanting a cage within an excised disc space in a patient in need of treatment, wherein the cage comprises an anterior wall comprising two cavities, wherein each cavity has a suitable shape to receive one keel; and (b) inserting two keels through the anterior wall such that the blade inserts into cancellous bone of the proximal superior and inferior vertebral bodies, wherein each keel contains a blade and two flanges, wherein the cross-section of the keels is in the shape of half of an I-beam. 